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Last Updated: December 22, 2024

Bismuth subsalicylate; metronidazole; tetracycline hydrochloride - Generic Drug Details


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What are the generic drug sources for bismuth subsalicylate; metronidazole; tetracycline hydrochloride and what is the scope of freedom to operate?

Bismuth subsalicylate; metronidazole; tetracycline hydrochloride is the generic ingredient in two branded drugs marketed by Ailex Pharms Llc and Casper Pharma Llc, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for bismuth subsalicylate; metronidazole; tetracycline hydrochloride
US Patents:0
Tradenames:2
Applicants:2
NDAs:2
Clinical Trials: 2
DailyMed Link:bismuth subsalicylate; metronidazole; tetracycline hydrochloride at DailyMed
Recent Clinical Trials for bismuth subsalicylate; metronidazole; tetracycline hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
M.D. Anderson Cancer CenterPhase 2

See all bismuth subsalicylate; metronidazole; tetracycline hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for bismuth subsalicylate; metronidazole; tetracycline hydrochloride

US Patents and Regulatory Information for bismuth subsalicylate; metronidazole; tetracycline hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ailex Pharms Llc BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE bismuth subsalicylate; metronidazole; tetracycline hydrochloride TABLET, CHEWABLE, TABLET, CAPSULE;ORAL 202584-001 Nov 30, 2018 RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Casper Pharma Llc HELIDAC bismuth subsalicylate; metronidazole; tetracycline hydrochloride TABLET, CHEWABLE, TABLET, CAPSULE;ORAL 050719-001 Aug 15, 1996 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Bismuth subsalicylate; metronidazole; tetracycline hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Bismuth Subsalicylate, Metronidazole, and Tetracycline Hydrochloride

Introduction

Bismuth subsalicylate, metronidazole, and tetracycline hydrochloride are key components in the treatment of various gastrointestinal infections, particularly those caused by Helicobacter pylori (H. pylori). This combination is widely used in therapies aimed at eradicating H. pylori and treating duodenal ulcer disease. Here, we delve into the market dynamics and financial trajectory of these medications.

Market Overview

The market for bismuth subsalicylate, metronidazole, and tetracycline hydrochloride is influenced by several factors, including the prevalence of H. pylori infections, the effectiveness of the treatment regimen, and the presence of alternative therapies.

Prevalence of H. pylori Infections

H. pylori infections are a significant global health issue, affecting approximately 50% of the world's population. This high prevalence drives the demand for effective treatments, making the combination of bismuth subsalicylate, metronidazole, and tetracycline hydrochloride a crucial part of gastrointestinal healthcare[2].

Treatment Regimens

The combination therapy involving bismuth subsalicylate, metronidazole, and tetracycline hydrochloride, often used in conjunction with an acid blocker like omeprazole, is highly effective in eradicating H. pylori and treating duodenal ulcers. This regimen has been shown to reduce the risk of duodenal ulcer recurrence significantly[2][5].

Market Size and Forecast

Tetracycline Hydrochloride Market

The tetracycline hydrochloride market is expected to grow at a Compound Annual Growth Rate (CAGR) of 3 to 5% from 2024 to 2031. This growth is driven by the increasing demand for antibiotics in medical applications. The market is segmented by application (medical), product concentration (250 mg/L, 500 mg/L), and geographical regions (North America, Europe, Asia-Pacific, etc.)[3].

Combination Therapy Market

The market for combination therapies involving bismuth subsalicylate, metronidazole, and tetracycline hydrochloride is also on the rise. This is due to the high efficacy of these regimens in treating H. pylori infections and duodenal ulcers. The combination therapy market benefits from the synergistic effects of these medications, making it a preferred treatment option for healthcare providers[2][5].

Financial Trajectory

Revenue Growth

The revenue generated from the sale of bismuth subsalicylate, metronidazole, and tetracycline hydrochloride is expected to increase steadily over the forecast period. This growth is driven by the increasing incidence of gastrointestinal infections and the expanding healthcare infrastructure in developing regions[3].

Key Players

Companies such as Lgm Pharm, Vwr, Cayman Chemical, and Ningxia Qiyuan are key players in the tetracycline hydrochloride market. These companies invest heavily in research and development to improve the efficacy and safety of their products, which in turn drives market growth[3].

Challenges and Opportunities

Drug Resistance

One of the significant challenges facing the market is the development of drug-resistant bacteria. The misuse or overuse of antibiotics can lead to reduced efficacy, necessitating the development of new treatment regimens. However, this also presents an opportunity for pharmaceutical companies to innovate and develop new antibiotics and combination therapies[2].

Interaction Between Medications

The interaction between bismuth subsalicylate and tetracycline hydrochloride, particularly the effect of Veegum on tetracycline bioavailability, is a critical consideration. Studies have shown that Veegum, an excipient in liquid formulations of bismuth subsalicylate, can significantly reduce tetracycline bioavailability. This knowledge can guide the development of more effective formulations[4].

Regulatory Environment

Approval and Usage

Bismuth subsalicylate was first approved by the FDA in 1939 and is widely used in over-the-counter medications like Pepto-Bismol. The combination therapy involving bismuth subsalicylate, metronidazole, and tetracycline hydrochloride is approved for the treatment of H. pylori infections and duodenal ulcer disease. Regulatory bodies emphasize the importance of using these medications only for proven or strongly suspected bacterial infections to prevent the development of drug-resistant bacteria[1][2].

Adverse Effects and Safety

Adverse Reactions

The combination therapy can have several adverse effects, including cutaneous reactions, neurological signs, and the potential for microbial overgrowth. It is crucial for healthcare providers to monitor patients closely for these reactions and adjust the treatment regimen accordingly[2].

Market Segmentation

By Application

The market is segmented by application, with the medical sector being the primary user of these medications. The increasing demand for effective treatments in this sector drives the market growth[3].

By Product

The market is also segmented by product concentration, with 250 mg/L and 500 mg/L being common concentrations for tetracycline hydrochloride. This segmentation helps in tailoring the treatment regimens to specific patient needs[3].

By Geography

Geographically, the market is divided into regions such as North America, Europe, Asia-Pacific, and others. The Asia-Pacific region is expected to show significant growth due to the large population and increasing healthcare infrastructure[3].

Key Takeaways

  • High Efficacy: The combination of bismuth subsalicylate, metronidazole, and tetracycline hydrochloride is highly effective in treating H. pylori infections and duodenal ulcers.
  • Market Growth: The market for these medications is expected to grow at a CAGR of 3 to 5% from 2024 to 2031.
  • Regulatory Considerations: These medications should be used only for proven or strongly suspected bacterial infections to prevent drug resistance.
  • Adverse Effects: Close monitoring is necessary to manage potential adverse reactions.
  • Geographical Expansion: The Asia-Pacific region is expected to drive significant market growth.

FAQs

Q: What is the primary use of the combination therapy involving bismuth subsalicylate, metronidazole, and tetracycline hydrochloride?

A: The primary use is to treat H. pylori infections and duodenal ulcer disease.

Q: How does Veegum affect the bioavailability of tetracycline hydrochloride?

A: Veegum, an excipient in liquid formulations of bismuth subsalicylate, can significantly reduce tetracycline bioavailability by adsorbing the tetracycline[4].

Q: What are the common adverse effects of this combination therapy?

A: Common adverse effects include cutaneous reactions, neurological signs, and the potential for microbial overgrowth[2].

Q: Why is it important to use these medications only for proven or strongly suspected bacterial infections?

A: To prevent the development of drug-resistant bacteria and maintain the effectiveness of the medications[2].

Q: What is the expected market growth rate for tetracycline hydrochloride from 2024 to 2031?

A: The market is expected to grow at a CAGR of 3 to 5%[3].

Sources

  1. DrugBank: Bismuth subsalicylate: Uses, Interactions, Mechanism of Action.
  2. Drugs.com: Bismuth, Metronidazole and Tetracycline Capsules.
  3. Market Research Intellect: Global tetracycline hydrochloride market size and forecast.
  4. PubMed: Reduced tetracycline bioavailability caused by magnesium aluminum silicate.
  5. HealthLink BC: Bismuth Subsalicylate/Metronidazole/Tetracycline - Oral.

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